BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 5890855 · Received August 19, 2016

    Report

    Report Number
    3008780134-2016-00009
    Event Type
    Injury
    Date Received
    August 19, 2016
    Date of Event
    July 20, 2016
    Report Date
    August 19, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED PLACING A CLIP AFTER OBSERVING A MUCOSAL TEAR. THE RETURNED CATHETER WAS VISUALLY INSPECTED FOR ISSUES THAT MAY HAVE CONTRIBUTED TO THE USER'S OBSERVATION. NO NONCONFORMANCES OR DEFECTS WERE IDENTIFIED ON THE DEVICES. THE DATA FROM THE RETURNED CONTROLLER WAS DOWNLOADED AND ANALYZED. THE DATA SHOWS FIVE ABLATION CYCLES; WHICH ARE COMPRISED OF FOUR COMPLETE 10-SECOND TREATMENTS AND ONE PARTIAL 10-SECOND TREATMENT DUE TO THE OPERATOR RELEASING THE TRIGGER. THE PARTIAL CYCLE OCCURRED ON THE FOURTH TREATMENT. THE PEAK BALLOON PRESSURE WAS 3.95 PSIG AND OCCURRED ON THE FIRST TREATMENT. THE RETURNED CATHETER WAS TESTED WITH THE RETURNED CONTROLLER AND NO ISSUES WERE IDENTIFIED, AND THE DEVICE WAS FOUND TO OPERATE WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE CUSTOMER'S OBSERVATION WAS UNABLE TO BE DETERMINED FROM THE DEVICE ANALYSIS AND DID NOT APPEAR TO BE RELATED TO ANY DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A MUCOSAL TEAR. THE TEAR WAS CLIPPED AS A PRECAUTIONARY STEP BECAUSE THE PATIENT WAS ON PLAVIX AND ASPIRIN. THE BLEEDING APPEARED TO STOP PRIOR TO PLACING THE CLIP, BUT THE PHYSICIAN PROCEEDED WITH CLIPPING OUT OF CAUTION. THIS WAS THE SECOND CRYOBALLOON TREATMENT FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540688 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT, CRYOGENIC GEH C2 THERAPEUTICS, INC. FG1012, FG1009 06102016-01, 04222016-01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention