BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1569875 · Received December 30, 2009

    Report

    Report Number
    3004534508-2009-00003
    Event Type
    Death
    Date Received
    December 30, 2009
    Date of Event
    December 11, 2009
    Report Date
    December 28, 2009
    Manufacturer
    CSA MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDICAL ADVISOR TO CSA MEDICAL REVIEWED THIS SITUATION WITH THE ATTENDING PHYSICIAN. IN THE OPINION OF THE TREATING PHYSICIAN, THE TREATMENT DID NOT APPEAR TO CONTRIBUTE TO THE DEATH. A CSA MEDICAL PERSONNEL EVALUATED THE CONSOLE AND FOUND IT TO BE OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A PT WITH EXTENSIVE DISEASE TO INCLUDE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, ANEMIA AND SIGNIFICANT HISTORY OF SMOKING, UNDERWENT CRYOSPRAY TREATMENT FOR MULTI-FOCAL SQUAMOUS CELL DYSPLASIA OF THE ESOPHAGUS AND BARRETTS ESOPHAGUS. THE PHYSICIAN TREATED TWO AREAS IN THE ESOPHAGUS. THE PT WAS NOTED TO BE STABLE PRIOR, DURING, AND AFTER EACH TREATMENT. BEFORE THE PHYSICIAN BEGAN TO TREAT THE THIRD AREA WITH CRYOSPRAY, THE PT STOPPED BREATHING. DESPITE AGGRESSIVE RESUSCITATION EFFORTS, THE PT EXPIRED. THE EXACT CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOSPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL INC. CC2-NAM

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death