BEUDAMED
    FDA Enforcement Class II Terminated

    C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.

    Recall: Z-0970-2019 · Reported March 13, 2019

    Enforcement

    Recall Number
    Z-0970-2019
    Event ID
    81695
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PENTAX of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2019
    Initiation Date
    December 3, 2018
    Classification Date
    March 1, 2019
    Termination Date
    August 21, 2020
    Address
    303 Convention Way, Ste 1, Redwood City, CA, 94063-1465, United States

    Description

    C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.

    Reason

    The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.

    Code Info

    All lot numbers

    Distribution

    Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.

    Quantity

    45