C2 CRYOBALLOON C2 CryoBalloon Ablation System

Integration Made Easy

NEXT LEVEL EFFICIENCY

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Ready to ablate a wide range of patients

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Patients experienced less post-procedure pain and need for narcotic medication

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Transparent compliant balloon pushes tissue flat for better apposition and controlled therapeutic delivery. With advanced rotational and translational capabilities, physicians can selectively target and ablate diseased areas while sparing healthy tissue. Intuitive controls give physicians total control of balloon inflation, deflation, diffuser positioning, and ablation.

Enhanced visualization and control

GET HIGHLY FOCUSED ASSISTANCE In your exams

Generating a robust clinical data pipeline in Barrett’s esophagus and beyond Highly effective and durable response through 2 years

No disease progression noted in a single patient at 2 years (N=41)

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Fast and easy-to-use Streamlined procedure takes approximately 15 to 30 minutes, depending on the amount of BE present. Minimal capital investment required. . On-demand with simple storage • Minimal set-up time • Compact, lightweight, portable system can be moved throughout care setting • Disposable cartridges allow for easy storage Smart, intuitive interface Hand-held touchscreen controller provides system feedback to the user.

Practice integration made easy with simplicity and speed

PENTAX Medical US Website

2) Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide C2 CryoBalloon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus. Gastroinstestinal Endoscopy Volume 88, No. 3 2018 4) Canto MI. Safety , efficacy and durability of endoscopic nitrous oxide CryoBalloon ablation for eradication of Barrett’s neoplasia. Poster presented at: Digestive Disease Week, June 2-5, 2018. Washington DC. Van Munster SN, Overwater A, Haidry R, Bisschops R, Bergman J, Weusten BL. Focal CryoBalloon verses radiofrequency ablation of dysplastic Barrett’s esophagus: impact on treatment response and postprocedural pain. Clinical Endoscopy. 2018 Volume 88 No. 5 795-803. 5) Dumot JA. The little engine that could. Gastrointestinal Endoscopy. 2018; 87(2): 582-583.

A new way to treat Barrett’s Esophagus

Prof Timo Rath, Professor of Endoscopy and Molecular Imaging, University of Erlangen, Nuremberg, Germany

I‘m very confident that PENTAX Medical DISCOVERY™ will translate into increasing our Adenoma Detection Rate and therewith contribute to reducing colorectal cancer mortality.

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Prof Peter Siersema, Professor of Endoscopic Gastrointestinal Oncology, Editor-in-Chief, Endoscopy, Radboud University, Netherlands

Computer-aided detection has been shown to increase the detection of pre-cancerous colorectal lesions. The introduction of the PENTAX Medical DISCOVERY™artificial intelligence system opens the door to a new era where endoscopists and PENTAX Medical DISCOVERY™ jointly reduce health-care costs by decreasing the prevalence of colorectal cancer.

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Clinical Data Pipeline

Highly safe and effective in both naïve and refactory patients with Barrett’s Esophagus. New catheter designs reach tubular structures, gastroesophageal junction (GEJ), and lesions big and small.

DISCOVERY™ is an innovative device working with Artificial Intelligence. It is able to support you in the detection of unremarkable lesions and directs your attention to potential lesions. It does this in real-time, visually and with sound signals.

Exceeding expectations A vital part of your comprehensive offering for patients with Barrett’s esophagus with dysplasia

PENTAX Medical EMEA

PENTAX Medical US Website

Clinical Data Pipeline

Integration Made Easy

Peak pain was lower after CryoBalloon ablation (median VAS 2 vs. 4, P < .01)

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Visualization and Control

1) Wani S, Muthusamy VR, Shaheen NJ, Yadiapeti R, Wilson R, Abrams JA, et al. Development of quality indicators for endoscopic eradication therapies in Barrett’s esophagus: the TREAT-BE (Treatment with Resection and Endoscopic Ablation Techniques for Barrett’s Esophagus) Consortium. Am J Gastroenterol 2017; 112(7): 1032-1048. 2) Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide C2 CryoBalloon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus. Gastroinstestinal Endoscopy Volume 88, No. 3 2018

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Ablation Range

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C2 CryoBalloon Pear Catheter at the GEJ

C2 CryoBalloon Focal Standard Catheter ablating treatment naïve tissue

This device changes how you see Barrett’s esophagus

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“With C2, I can offer my patients the latest and most effective treatment options and develop a more comprehensive Barrett’s center”

— Harshit S. Khara, MD. FACG, FASGE Clinical Associate Professor of Medicine Director of Endoscopy Geisinger Medical Center

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No patient required narcotic medication after Day 7 following treatment

Median number of ablation procedures was 3

95%

1-year results

2-year results

CED

88%

90%

CEIM

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Duration of pain was shorter after CryoBalloon ablation (median 2 vs. 4 days, P < .01)

Mild pain was reported by 27% of patients immediately after cryoblation and by 14% after 2 days

Cryoblation is significantly less painful than RFA

PENTAX Medical America, Inc. 3 Paragon Drive Montvale, NJ 07645 United States

PENTAX Medical Website

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T: +1 866 979 5022 F: +1 866 584 8523 E:

info@pentaxmedical.com

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2) Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide C2 CryoBalloon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus. Gastroinstestinal Endoscopy Volume 88, No. 3 2018 3) Canto MI. Safety , efficacy and durability of endoscopic nitrous oxide CryoBalloon ablation for eradication of Barrett’s neoplasia. Poster presented at: Digestive Disease Week, June 2-5, 2018. Washington DC. 6) PENTAX Medical C2 CryoBalloon Ablation System Instructions for Use (IFU). LBL 1028 Master Document Rev. M 7) Kunzli HT, Scholvinck DW, Meijer SL, Seldenrijk KA, Bergman JGHM, Weusten BLAM. Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett’s esophagus islands. Endoscopy. 2017; 49(2): 169-175. 8) Canto MI, Trindade AJ, Abrams J, Rosenblum M et al. Multifocal CryoBalloon Ablation for Eradication of Barrett’s Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial. Am J Gastroenterol. 2020; 115:1879-1890.

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Practice integration made easy with simplicity and speed

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