BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6953223 · Received October 16, 2017

    Report

    Report Number
    3008780134-2017-00015
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 22, 2017
    Report Date
    September 22, 2017
    Manufacturer
    C2 THERAPEUTICS
    Product Code
    GEH
    UDI-DI
    00854924006125
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRADYCARDIA MAY BE PROCEDURE-RELATED OR DEVICE-RELATED. BRADYCARDIA MAY OCCUR SECONDARY TO ABLATION BECAUSE OF THE PROXIMITY OF THE ESOPHAGUS TO THE VAGUS NERVE. VAGAL STIMULATION MAY RESULT FROM DISTENTION BY THE BALLOON, THE ABLATION ITSELF, OR ANESTHETIC. THE DATA FROM THE DEVICE WAS DOWNLOADED AND REVIEWED. A TOTAL OF 7 COMPLETE ABLATIONS WERE PERFORMED FOLLOWED BY A PARTIAL TREATMENT ENDED EARLY. AT THE END OF THE PROCEDURE THERE IS AN ERROR FOR HIGH BALLOON PRESSURE WHERE PRESSURE SUDDENLY SPIKED. THE ROOT CAUSE OF THIS PRESSURE IS UNDETERMINED. THE CONTROLLER WAS RUN WITH A KNOWN WORKING CATHETER. A TOTAL OF THREE 8-SECOND ABLATIONS WERE PERFORMED AND NO ISSUES WERE NOTED WITH CONTROLLER FUNCTIONALITY. CONTROLLER PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    C2 THERAPEUTICS BECAME AWARE OF AN EVENT ON (B)(6) 2017 A COMMERCIAL PATIENT WITH HGD EXPERIENCED BRADYCARDIA DURING A CRYOBALLOON PROCEDURE. THERE WERE 8 ABLATIONS PERFORMED WITH THE CRYOBALLOON SYSTEM. THE PATIENT WAS BRADYCARDIC INTO THE 20-30S, THE PATIENT WAS THEN GIVEN ATROPINE WHICH RESOLVED THE BRADYCARDIA. THE PATIENT'S HEMODYNAMICS STABILIZED AND HE WOKE UP FROM ANESTHESIA WITHOUT COMPLICATIONS. THE PATIENT WENT HOME ON THE SAME DAY AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731941 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES GEH C2 THERAPEUTICS FG 1012 08232017-02 00854924006125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention