BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6072699 · Received November 2, 2016

    Report

    Report Number
    3008780134-2016-00014
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 1, 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 CONTROLLER DATA WAS DOWNLOADED AND ANALYZED. NO ISSUES WERE OBSERVED, AND DEVICE FUNCTIONED AS EXPECTED. THE PHYSICIAN DETERMINED THAT THE EVENT IS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF INCREASED ABDOMINAL BLOATING AT THE DAY 1 FOLLOW-UP CALL. AT THE DAY 4 FOLLOW-UP CALL, THE PATIENT HAD AN ADDITIONAL COMPLAINT OF SHORTNESS OF BREATH. THE PHYSICIAN REFERRED THE PATIENT TO THE LOCAL EMERGENCY DEPARTMENT. THE PATIENT WAS ASSESSED WITH A CT OF THE ABDOMEN FOR POSSIBLE PERFORATION. THE CT WAS NEGATIVE FOR PERFORATION. THE PATIENT RECEIVED AN INHALER AND RESPIRATORY TOILET WITH RESOLUTION OF THE SHORTNESS OF BREATH. THE EMERGENCY DEPARTMENT PHYSICIAN ATTRIBUTED THE SHORTNESS OF BREATH TO THE PATIENT'S HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND THE PATIENT WAS GIVEN PREDNISONE FOR 5 DAYS TO ADDRESS THE CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PHYSICIAN BELIEVES THAT THIS EVENT IS NOT RELATED TO THE CRYOBALLOON ABLATION TREATMENT. A HOSPITAL REPRESENTATIVE SUBSEQUENTLY SPOKE WITH THE PATIENT AFTER HIS DISCHARGE, AND HIS ABDOMINAL BLOATING HAD RETURNED TO BASELINE AND NO LONGER HAD SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723859 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESORRIES GEH C2 THERAPEUTICS, INC. FG1012, FG1009 08112016-01, 06092016

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization